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DiviTum-TKa Assay for Breast Cancer

N/A
Recruiting
Led By Mariya Rozenblit
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have histologically confirmed metastatic ER-positive (> 10%), PR-positive or PR-negative, and HER2-negative (0 by immunohistochemistry [IHC] or if +1 or +2 by IHC, not amplified by fluorescence in situ hybridization [FISH]) breast cancer as per the 2018 joint American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Participants must be starting CDK4/6 inhibitor and endocrine therapy as part of first-line therapy per standard of care and be previously CDK4/6 inhibitor-naïve
Must not have
Participants without evidence of metastatic disease prior to registration
Participants with prior use of CDK4/6 inhibitor therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Summary

This trial is testing a new method called DiviTum to see if it can help determine the right levels of medications for breast cancer patients. The trial will focus on patients with a specific type of breast

Who is the study for?
This trial is for individuals with ER/PR positive, HER2-negative metastatic breast cancer who are currently receiving CDK 4/6 inhibitors. It aims to optimize medication levels using the DiviTum-TKa test, which measures a biomarker associated with cell growth.
What is being tested?
The study tests if the DiviTum-TKa assay can help find the best dose of CDK 4/6 inhibitor medications and improve treatment by monitoring drug interactions and patient compliance in those undergoing first-line therapy for metastatic hormone-positive breast cancer.
What are the potential side effects?
Since this trial focuses on optimizing medication dosage through testing rather than introducing new drugs, side effects may be more related to adjustments in current treatments or potential issues from drug-drug interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is ER-positive, may be PR-positive or negative, and is not HER2-positive.
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I am starting CDK4/6 inhibitor and hormone therapy for the first time.
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I have not started CDK4/6 inhibitor therapy yet.
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I am 18 years old or older.
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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has not spread to other parts of my body.
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I have previously used CDK4/6 inhibitor therapy.
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I am unable to give informed consent for the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with thymidine kinase activity (TKa) values that switch from profile 3 to profile 1 or 2 after medication compliance and drug-drug interaction assessment
Rate of improvement in CDK4/6 inhibitor response (i.e. moving from profile 3 to profiles 1 or 2)
Secondary outcome measures
CDK4/6 inhibitor response via TKa levels upon CDK4/6 inhibitor dose reductions or changes in CDK4/6 inhibitor regimen due to adverse events
Clinical benefit rate (CBR) in patients with sub-optimal (profile 3) and optimal (profiles 1 and 2) CDK4/6 inhibitor response
Comparison of CDK4/6 inhibitor response profiles across the three CDK 4/6 inhibitors
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Health services research (DiviTum-TKa)Experimental Treatment1 Intervention
Patients undergo collection of blood samples per SOC on days 1, 15, and 28 of cycle 1, days 15 and 28 of cycle 2, days 15 and 28 of cycle 3, and day 28 of subsequent cycles for up to 12 cycles for analysis by DiviTum-TKa in the absence of disease progression or unacceptable toxicity.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,907 Previous Clinical Trials
3,018,999 Total Patients Enrolled
27 Trials studying Breast Cancer
3,235 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,950 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 Patients Enrolled for Breast Cancer
Mariya RozenblitPrincipal InvestigatorYale University
~18 spots leftby May 2025
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